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Efficacy of a New Composition (BU002) for Debridement of Chronic Cutaneous Ulcers

RecruitingNAAges 60 Years - anyAllUniversidad del Desarrollo
NCT07607106 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study is testing a new liquid treatment for people with long-lasting (chronic) wounds, such as venous leg ulcers or diabetic foot ulcers. These wounds can be difficult to heal because they often contain dead tissue and bacteria. The new product is designed to help clean the wound and remove dead tissue, which may help the wound heal better. It will be compared to a commonly used treatment called Polyhexanide gel. About 80 people aged 60 years or older will take part in this study. Each participant will be randomly assigned (like flipping a coin) to receive either the new treatment or the standard treatment. Neither the participant nor most of the study team will know which treatment is being used during the study to ensure fair results. The study will last 4 weeks. Participants will attend eleven visits at the wound care center. During these visits, trained nurses will clean and t

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📋 Eligibility rules (as published)
Inclusion Criteria A pure or mixed venous ulcer, or a diabetic, neuropathic, or neuroischemic foot ulcer, greater than or equal to 4 cm² and less than or equal to 30 cm² with critical colonization. A duration of the ulcer greater than or equal to 2 months and less than or equal to 2 years. Age over 60 years: due to the higher prevalence of ulcers in adults over 60 years of age. An ankle-brachial index between 0.6 and 1.3. Exclusion criteria Morbid obesity (BMI \> 35) History of cancer treatment in the last year Uncontrolled diabetes (Glycated Hemoglobin above 10 mg/dL) Uncontrolled hypertension (blood pressure readings greater than 140/90 mmHg) Patients with a known allergy to the components of the products under study. Patients with signs of infection or undergoing antibiotic therapy.
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What it tests

  • BU002
  • Polyhexanide 0.1% and betaine 0.1% gel
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Where

1 site
Universidad del Desarrollo
Santiago, Chile
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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